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Medical Device Lifecycle Management Leader

3 months ago

Harefield, Greater London, United Kingdom Norgine Full time

Norgine's 3D Career Experience

At Norgine, we offer a unique 3D career experience where colleagues Dare, Drive, and Develop themselves and their community. This fully-rounded experience has no limits, allowing individuals to bring their passion, focus, and curiosity to a supportive environment. In return, employees receive ongoing development, a sense of belonging, and a company that prioritizes wellness.

About the Role

We are seeking a highly motivated and experienced Associate Director to lead our Medical Device Lifecycle Management team. This individual will play a critical role in ensuring the successful development, launch, and maintenance of our medical device portfolio.

Key Responsibilities

  • Serve as the primary regulatory point of contact for all medical device-related inquiries.
  • Oversee and provide guidance to our Regulatory Service Provider on device maintenance activities.
  • Represent Regulatory Affairs Lifecycle Management both internally and externally, collaborating with cross-functional teams and stakeholders.
  • Effectively manage your workload and regulatory activities, ensuring timely completion of tasks and adherence to established timelines.
  • Maintain a comprehensive understanding of evolving regulations and industry standards within the medical device sector.
  • Continuously explore opportunities for process improvement and efficiency within the lifecycle management framework.
  • Uphold strict compliance with all relevant policies and procedures.

Qualifications

  • A Bachelor's or Master's degree in a scientific or healthcare-related field is preferred.
  • Extensive experience in regulatory affairs, specifically within the medical device industry.
  • Demonstrated expertise in the development and maintenance of medical devices throughout their lifecycle.
  • Proven leadership experience, including managing teams or overseeing staff.
  • Experience in managing external service providers, ensuring effective collaboration and performance.